trial where we put a variety of different leads into the ‘virtual’ heart. We
changed the locations to meet all the
variables – where you put it, how much
slack to lead, how stiff the lead is, etc.

If you applied all those potentials in areal patient trial, times the number ofdifferent types of patients, hundreds ofthousands of patients would be neededfor a statistical average.”“In clinical trials, beyond being veryexpensive and invasive, it is very difficultto have a true population distribution.

The target may be to test it on a millionpeople but in reality they may only beable to test only a few hundred -- oronly dozens. It is too time consuming,too invasive and also when testing newproducts or devices on living patients,bad things can happen. It is very hard toknow whether you’ve got a true repre-sentation of the full population.”“The worst thing is for a com-pany to run a clinical trial and getinconclusive evidence. It happens allthe time. We can help them elimi-nate that by interperating the data,providing a virtual simulation of themechanism which will help them tocreate a real life trial that will achievethe end point effectively. Humantrials are not going to go away, butif we can reduce these to a fractionand help to ensure the results required,everybody wins.”

A Future Without Boundaries

The Living Heart Project will continue
to add new areas. However, the company itself has an eye on the future and
plans to develop similar technology for
many other areas.

Levine says that they are veryactive in the orthopedic area – hip/joint replacements. “What is drivingthat industry more than anything isthe need for personalized implantsfor a person’s unique anatomy – andlifestyle. If I play golf for instance,my hip or knee has different needsthan a person who doesn’t. Devel-opers will be able to create uniquejoints and test them within varioustolerances and do it virtually before-the-fact.”SIMULIA’s next biggest area ofinterest is in the brain. Recently, manydevices have been developed forimplanting into the brain for variousconditions, also into the spine – andsometimes together, where one feedsthe other.

“We’re interested in that for a variety of reasons, but mainly to stimulate the brain electrically rather than
chemically which is what they are

Figure 4. SIMULIA plans to eventually create a digital twin that replicates their anatomy and all their organs, internal systems, anddefects. A viewable, physiological model that is updated as a living medial record over time.